# K973928: Beckman Urine Protein Calibrator (Ucal)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Dec 1, 1997 after 47 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895883 (1989). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895883: Beckman MA Microalbumin Reagent Kit, Beckman Instruments, Inc. (1989) Summary page 1.
- K926272: Beckman Transferrin Kit, Beckman Instruments, Inc. (1993) Summary page 1.
- K933078: Beckman Alpha-1-Microglobulin (A1M) Reagent, Beckman Instruments, Inc. (1994) Summary page 1.
- K951635: Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control, Beckman Instruments, Inc. (1995) Summary page 1.

## Most influential descendants
- K994325: Synchron CX Systems Microalbumin Calibrator (2000), 0 descendants of its own

## Indications for use
UCAL (Urine Protein Calibrator), when used in conjunction with Beckman microalbumin (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and urine immunoglobulin G (IGU) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.

Source page: https://510kreport.com/device/K973928
Methodology: https://510kreport.com/methodology